A Type I Hybrid Effectiveness-Implementation Trial of MIO

Part of paid clinical trials in Springfield, Massachusetts.

Sponsor
Baystate Medical Center
Study ID
NCT07168642
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mothering from the Inside Out — BEHAVIORAL
    Mothering from the Inside Out (MIO) is an evidence-based individual psychotherapy designed to help caregivers in recovery build stronger relationships with their children. In MIO, caregivers are helped to build their ability to reflect on their own mental states and how they arose. Often, we find that the thoughts and feelings that drive caregiving behavior are actually triggered by early experiences of being cared for. MIO thus aims to provide a safe, therapeutic space where caregivers' internal experiences are taken seriously and clinicians are genuinely interested, curious, and collaborative. MIO also involves helping caregivers to reflect on the possible mental states underlying their children's behavior. We find that by providing some information about child development through an attachment lens, this can help parents see through their children's eyes and feel less stressed.

Study Details

Mothers with substance use disorders face unprecedented stress in their roles as parents working to care for their children while maintaining healthy recovery. Mothering from the Inside Out (MIO) is the first attachment-based parenting intervention designed specifically for mothers in recovery from substance use disorders that has been shown to have benefit for both mother and child in multiple randomized controlled trials. This project will: (a) test the effectiveness of MIO among women in outpatient treatment under 'real-world' conditions, (b) evaluate implementation in different settings, and (c) assess key implementation factors to support optimal uptake and treatment in future dissemination studies; closing an important science-to-service gap for an underserved population in an effort to support maternal and child health simultaneously.

Key Dates

Start date
Dec 18, 2025
Status verified
Jan 2026
Primary completion
Jan 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    Mothering from the Inside Out (MIO) + treatment as usual (TAU)
  • No Intervention: Control
    Treatment as usual (TAU)

Primary Outcome Measure

Parental Reflective Functioning [ Time Frame: Baseline, post treatment (week 21) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baystate Medical CenterSpringfieldMassachusetts01199
Elizabeth Peacock-Chambers, MD, MS
[email protected]
413-794-8301
Briana L Jurkowski, BS
[email protected]
413-794-8833
Elizabeth Peacock-Chambers, MD, MS (PRINCIPAL_INVESTIGATOR)
Amanda F Lowell, PhD (SUB_INVESTIGATOR)
Shankar Viswanathan, DrPH, MSc (SUB_INVESTIGATOR)

Find similar trials in Springfield, MA

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Baystate Medical Center· Springfield, MA

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